Assessing fetal growth detection methods in low-risk pregnancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of measuring symphysis fundal height (SFH) alone versus combining it with point of care ultrasound to assess fetal abdominal circumference in low-risk pregnant women after 35 weeks of gestation. Midwives trained in these measurement techniques will conduct evaluations at various gestational weeks, with formal obstetric ultrasounds performed if abnormalities are suspected. The goal is to improve the identification of small and large for gestational age infants, which can lead to better maternal and neonatal outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Maternal age ≥ 18 years and ability to give informed consent.
* Singleton gestation
* Ultrasound examination that confirms or revises the EDD before 14 weeks of gestational age
* Gestational age ≥ 35 weeks' gestation
* Normal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) when performed
* Spontaneously conceived pregnancy (i.e the current pregnancy is not the result of in vitro fertilization)

Exclusion Criteria:

* Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed
* Fetal malformations or soft markers identified on fetal anatomy survey
* Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criteria.
* Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.
* Cerclage in the current pregnancy
* History of intrauterine fetal demise
* History of fetal growth restriction or birth weight \> 4Kg in a previous pregnancy
* Fetal isoimmunization or alloimmunization
* Fetal demise in previous pregnancies
* Cancer (including melanoma but excluding other skin cancers). Dysplastic or pre-neoplatic conditions such as cervical intraepithelial neoplasia are admissible.
* Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).
* Renal disease with altered renal function (creatinine \> 0.9, proteinuria \> 300 mg/24 hour)
* Epilepsy or other seizure disorder
* Any collagen disease (lupus erythematosus, scleroderma, etc.)
* Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes). Liver disorders accounting for cholestasis (including cholestasis of pregnancy) if diagnosed prior to enrollment.
* Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb \> 9 gm/dl). Patients with sickle cell disease are excluded.
* Chronic pulmonary disease including asthma requiring regular use of medication and active TB. An asthma inhaler used on an as needed basis for a cold or an asthma attack is not considered regular use.
* Heart disease except mitral value prolapse not requiring medication
* Cardiovascular disorders: chronic hypertension, gestational hypertension or preeclampsia diagnosed prior to enrollment
* Infectious diseases: HIV, CMV, toxoplasmosis, parvovirus B19, HBV, HCV
* Chronic treatments with medications such as aspirin, steroids, anti-hypertensive agents, immunosuppressants, antineoplastic drugs.
* Prior laparoscopic or open uterine surgeries where the uterine cavity was entered (such as myomectomies)
* Resectoscopic myomectomies (prior resectoscopic polypectomies are not contraindications)
* Prior classical cesarean deliveries.

Where it's running

• Azienda Ospedaliero Universitaria Policlinico di Modena
  Modena, Modena, Italy Recruiting
• Cesena Hospital
  Cesena, Italy Not yet recruiting
• Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery, Monza, Italy.
  Monza, Italy Not yet recruiting

Study contacts

• Principal investigator: Giuseppe Chiossi, MD — University of Modena and Reggio Emilia, Modena Policlinico Hospital, Department of Obstetrics and Gynecology
• Study coordinator: Giuseppe Chiossi, MD
• Email: ossidi74seppie@yahoo.it
• Phone: +39 059 4225607

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LMWH for Neonatal Outcomes in Isolated Oligohydramnios

  This trial tests whether adding a low-molecular-weight heparin shot to standard care helps babies born after oligohydramnios have better outcomes.

  Recruiting Phase 4 PAEC General Hospital, Islamabad · Islamabad, Federal · NCT07907731

• Registry for Preterm Premature Rupture of Membranes

  This study is collecting information about pregnancies affected by early water breaking to see what causes it and how to improve care for both moms and babies.

  Recruiting American Alliance for pProm Support · Denver, Colorado · NCT02997345

• Predicting Breast Cancer Subtypes in BRCA-Associated HR+/HER2-Negative Disease

  This study tests whether BRCA1/BRCA2-related, hormone-receptor–positive, HER2-negative breast cancers have distinct molecular subtypes that might respond differently to endocrine therapy or CDK4/6 inhibitors.

  Recruiting at 6 sites University of Modena and Reggio Emilia · Genova and 5 other locations · NCT07617025

• Robotic technologies to reduce apathy in dementia

  This project will test whether two different home-based robotic programs can help people with mild cognitive impairment or dementia who have apathy become more motivated and engaged compared with standard occupational therapy.

  Recruiting at 2 sites University of Modena and Reggio Emilia · Milan, Italy and 1 other locations · NCT07404410

• HOXB7 and related lung and blood biomarkers in pulmonary fibrosis

  This pilot study will test whether levels of HOXB7 and other molecules in lung tissue and blood exosomes can serve as biomarkers in adults with pulmonary fibrosis.

  Recruiting University of Modena and Reggio Emilia · Modena · NCT07373288

• Personalized digital training for cognitive fitness in people with mild cognitive impairment

  This study tests whether a personalized home-based digital program (RICORDO) helps people aged 50 and older with mild cognitive impairment or subjective cognitive decline manage their health and daily life better than a paper-and-video education program.

  Recruiting at 2 sites University of Modena and Reggio Emilia · Modena, Reggio Nell'Emilia (RE) and 1 other locations · NCT07286448

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.